Randomized Study on the Efficacy and Safety of Pegylated Interferon and Ribavirin in Hepatitis C Virus Infection After Liver Transplantation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Histological improvement (decrease in at least one fibrosis stage in follow-up liver biop
研究概览
简要总结
The purpose of this study was to evaluate the efficacy (and safety) of antiviral therapy in patients with chronic hepatitis C after liver transplantation. The only approved drugs for treatment of hepatitis C are pegylated interferon and ribavirin.
详细描述
Hepatitis C recurrence after liver transplantation remains the main cause of graft loss after liver transplantation. Several strategies can be used to prevent or treat hepatitis C in the setting of liver transplantation. There are no controlled studies evaluating the efficacy and safety of antiviral treatment (using pegylated interferon and ribavirin) in liver transplant recipients. The main endpoint of this study was: 1) histological outcomes (effect of antiviral treatment on disease progression, i.e. liver fibrosis). The secondary endpoint were 1) Sustained virological response (persistent HCV-RNA clearance) and 2) Safety of pegylated interferon and ribavirin
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic hepatitis C defined by liver biopsy and presence of HCV-RNA
- •More than 6 months from liver transplantation
- •Written inform consent
排除标准
- •Severe hepatitis C recurrence (F3-F4 fibrosis stage, cholestatic hepatitis)
- •Double liver-kidney transplantation
- •Leucopenia (2000) or thrombocytopenia (40.000)
- •Anemia (Hemoglobin lower than 10 g/dL)
- •Renal failure (creatinine > 2 mg/dL)
- •Autoimmune disease
- •All contraindications for interferon and ribavirin therapy
结局指标
主要结局
Histological improvement (decrease in at least one fibrosis stage in follow-up liver biop
次要结局
- Sustained virological response (persistent HCV-RNA negativation)
- Safety of antiviral therapy